FDA 510(k) Application Details - K070699

Device Classification Name Powder, Porcelain

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510(K) Number K070699
Device Name Powder, Porcelain
Applicant PENTRON CERAMICS, INC.
500 MEMORIAL DR.
SOMERSET, NJ 08873 US
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Contact MEGAN VERNAK
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 03/13/2007
Decision Date 06/29/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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